‘What a mess’: How biotech startups grappled with SVB’s collapse
Bio Pharma Dive
MARCH 13, 2023
The bank’s failure caused some companies to question whether they could pay employees, while forcing many others to take steps to calm nervous investors.
Mon.Mar 13, 2023
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US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy
Pharmaceutical Technology
MARCH 13, 2023
The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Trofinetide is a synthetic version of the tripeptide glycine-proline-glutamate (GPE) naturally occurring molecule. It increased the branching of dendrites and synaptic plasticity signals in animal trials.
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Pfizer to buy Seagen in $43B cancer drug deal
Bio Pharma Dive
MARCH 13, 2023
The acquisition would give Pfizer control of a top-selling lymphoma drug and a pipeline of medicines that have made the Seattle-based company one of the sector’s most valuable biotechs.
Sleep Disturbances Linked With Higher Dementia Risk, Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 13, 2023
If you needed another reminder of just how important quality sleep is to our health and well-being, a new study has linked three specific sleep problems with a change in risk of developing dementia.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Amylyx’s ALS drug sales impress Wall Street
Bio Pharma Dive
MARCH 13, 2023
In its first full quarter on the market, Amylyx’s Relyvrio generated revenue just shy of $22 million, or roughly five times what some analysts were forecasting a month ago.
IISc develops chemically modified nanosheets for biomedical applications like delivering drugs to diseased cells
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 13, 2023
The Indian Institute of Science (IISc) researchers from the Department of Organic Chemistry (DOC) and Materials Research Centre (MRC) have shown that surface modifications of two-dimensional molybdenum disulphide (2D-MoS) nanosheets can make them highly effective for applications like delivering drugs to diseased cells.
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Cytovance Biologics and Phenotypeca partner for biopharmaceutical manufacturing
Pharmaceutical Technology
MARCH 13, 2023
Cytovance Biologics has entered a collaboration deal with Phenotypeca to enhance the development of saccharomyces cerevisiae strain for biopharmaceutical manufacturing. The partnership is expected to expedite the development of high-performance yeast strains and improve the biologics production efficiency for biopharma clients. It will use the knowledge of Cytovance Biologics in microbial fermentation and the yeast strain development technology of Phenotypeca for producing high-quality expressin
Regulators backstop SVB deposits, offer emergency lending
Bio Pharma Dive
MARCH 13, 2023
SVB’s demise on Friday marked the nation’s largest bank failure since Washington Mutual collapsed in 2008, and sent shock waves through both the life sciences and tech sectors.
Sanofi signs deal to buy Provention Bio for $2.9bn
Pharmaceutical Technology
MARCH 13, 2023
Sanofi has signed an agreement to buy US-based biopharmaceutical firm Provention Bio in a deal valued at nearly $2.9bn. Under the deal, the company will start a cash tender offer to buy Provention Bio’s all outstanding shares for $25.00 per share in cash. With the acquisition, Sanofi will add a fully owned, first-in-class, disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D), Tzield, to its core asset portfolio in General Medicines.
Sanofi acquires diabetes drug via Provention buyout
Bio Pharma Dive
MARCH 13, 2023
The deal builds on a licensing agreement between Sanofi and Provention to market the first-of-its-kind treatment, called Tzield and approved to slow the disease’s progression.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need
STAT News
MARCH 13, 2023
An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.
Got muscle pain from statins? A cholesterol-lowering alternative might be for you
NPR Health - Shots
MARCH 13, 2023
New evidence shows bempedoic acid works to lower cholesterol and reduce the risk of heart attacks, without the muscle pain that some people suffer when taking statins. (Image credit: Digital Vision.
STAT+: Veterans Health Administration will cover the newest Alzheimer’s drug
STAT News
MARCH 13, 2023
In an unexpected move, the Veterans Health Administration decided that it will widely cover a new Alzheimer’s treatment , even as Medicare has decided to wait for additional data about the medicine before taking the same step. The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment.
A veterinarian says pets have a lot to teach us about love and grief
NPR Health - Shots
MARCH 13, 2023
Karen Fine says "I feel like I learn from my patients all the time. They really have skills and senses that we don't." Her new memoir is The Other Family Doctor.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Opinion: The second age of psychedelic therapies for mental health
STAT News
MARCH 13, 2023
Psychedelics like psilocybin and ketamine are being touted as the next generation of treatment for depression, anxiety, and other mental health issues. There’s no question that a next generation is needed. But it’s not like flipping a switch: These therapies involve a novel administration paradigm, acceptance by regulatory bodies, and public appreciation of their unique medicinal value.
Can you catch a hidden virus from a dog kiss or a cat cuddle?
NPR Health - Shots
MARCH 13, 2023
What's the risk of contracting a virus from your Fido or Kitty? It's not a frivolous question, as one cat-owning virologist explains. And there's another question: Can you give a virus to your pet?
STAT+: Pfizer buys Seagen, maker of targeted cancer drugs, for $43 billion
STAT News
MARCH 13, 2023
Pfizer said Monday it is acquiring Seagen, a maker of targeted cancer drugs, for $43 billion. The deal helps Pfizer, flush with cash but in need of new sources of revenue due to declining sales of Covid treatments, by adding a lineup of cancer drugs called antibody-drug conjugates that work by delivering chemotherapy directly to tumors.
Mediterranean diet associated with decreased risk of dementia
Medical Xpress
MARCH 13, 2023
Eating a traditional Mediterranean-type diet—rich in foods such as seafood, fruit, and nuts—may help reduce the risk of dementia by almost a quarter, a new study has revealed.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
STAT+: Buyer’s remorse: How a Medicare Advantage business is strangling one of its first funders
STAT News
MARCH 13, 2023
When NaviHealth began building a business around using algorithms to scrutinize the care of older patients a decade ago, one of the country’s largest chains of inpatient rehab and long-term care hospitals was among the first to invest. Select Medical cut a check of about $5 million — a rounding error for a conglomerate that generates more than $6 billion of revenue every year.
What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers
FDA Law Blog
MARCH 13, 2023
By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab
STAT+: Illumina has been ignoring its investors, but it can’t ignore Carl Icahn
STAT News
MARCH 13, 2023
Illumina, the DNA sequencing giant whose stock has fallen 40% in two years, already had problems. Now it has to contend with Carl Icahn. The granddaddy of activist investors announced Monday morning that he’s taken a stake in Illumina and wants three handpicked directors added to the company’s board. The message Illumina’s management should hear is this: Icahn usually gets much of what he wants.
Scientists reveal a potential new approach to treating liver cancer
Medical Xpress
MARCH 13, 2023
Scientists at the National Institutes of Health and Massachusetts General Hospital in Boston have uncovered a potential new approach against liver cancer that could lead to the development of a new class of anticancer drugs. In a series of experiments in cells and mice, researchers found that an enzyme produced in liver cancer cells could convert a group of compounds into anticancer drugs, killing cells and reducing disease in animals.
Accelerating Clinical Supply Through Integrated Drug Development
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
STAT+: Pharmalittle: Biogen exec who quarterbacked Aduhelm leaves; Pfizer to buy Seagen for $43 billion
STAT News
MARCH 13, 2023
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings and deadlines has returned. But you knew this would happen, yes? After all, the world continues to spin no matter how we try to slow it down. So to cope, we are firing up the coffee kettle and brewing cups of stimulation.
From grave robbing to giving your own body to science—a short history of where medical schools get cadavers
Medical Xpress
MARCH 13, 2023
In 1956, Alma Merrick Helms announced that she was bound for Stanford University. But she would not be attending classes. Upon learning that there was a "special shortage of women's bodies" for medical students, this semiretired actress had filled out forms to donate her corpse to the medical college upon her death.
STAT+: French pharma Sanofi buys maker of diabetes treatment for $2.9 billion
STAT News
MARCH 13, 2023
Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion. The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.
Yoga may help to prevent frailty in older adults
Medical Xpress
MARCH 13, 2023
A systematic review of 33 randomized controlled trials (RCTs) found that yoga improved gait speed and lower extremity strength in inactive older people. However, yoga did not seem to offer a benefit for frailty markers over activities like exercise or tai chi. The review is published in Annals of Internal Medicine.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
STAT+: 102 hours of chaos: How SVB’s collapse rattled the biotech industry
STAT News
MARCH 13, 2023
Paul Rennert was surprisingly energized after deplaning a transatlantic flight in Boston Thursday evening. He had just wrapped up weeks of international travel and investor meetings, and was pleased that even though the biotech industry was in the midst of one of the worst financing environments in years, venture capitalists had seemed receptive to the idea of investing in his startup, Aleta Biotherapeutics.
Providing clinicians with an AI sidekick to help to identify cirrhosis
Medical Xpress
MARCH 13, 2023
There is power and value in a highly skilled detective. Sherlock Holmes and his trusty sidekick, Watson, are famous for sifting through enormous amounts of data—identifying patterns and making predictions to uncover a mystery with ease. In the medical world, clinicians are detectives, making diagnoses and drawing conclusions based on their clinical judgment and available patient data.
With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs'
Fierce Pharma
MARCH 13, 2023
With $43B buyout, Pfizer sees cancer specialist Seagen as a 'goose' laying 'golden eggs' kdunleavy Mon, 03/13/2023 - 10:16
COVID-19 can cause 'face blindness,' according to new study
Medical Xpress
MARCH 13, 2023
COVID-19 can cause difficulty recognizing faces and navigational problems, according to a new Dartmouth study in Cortex.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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